St. Jude, firing back, posts 377 Medtronic Quattro lead deaths

The editor of the Heart Rhythm Society’s journal is sticking to his guns and refusing to retract an article linking some 22 deaths with St. Jude Medical’s (NYSE:STJ) recalled Riata defibrillator leads, despite the med-tech giant’s insistence that the study contains fundamental factual errors.

St. Jude fired back, backing up a prior claim that the study vastly undercounted the number deaths related to arch-rival Medtronic‘s (NYSE:MDT) Quattro Secure leads, published all 377 of the records from an FDA database of adverse medical events.

St. Jude posted on its Riata recall website today all 377 Quattro deaths it culled from the FDA’s database, calling on the study’s author, prominent cardiologist Dr. Robert Hauser, to definitively stand behind the 62 deaths he noted in his paper and inviting Medtronic to review the findings for itself.

Journal editor Dr. Douglas Zipes told the New York Times that the Hauser piece, which went online last month and is slated for print publication later in April, was peer-reviewed before it appeared on the journal’s website. And although Hauser has agreed to minor edits to adjust "inflection" ahead of print publication, "the bulk of the manuscript stays as is," Zipes told the newspaper.

The 62 Quattro deaths claimed by Hauser were not all-inclusive, but excluded reports that were either clearly unrelated to the implanted leads or too vague to define. Hauser’s study attributed 5 of the 62 Quattro deaths to lead-related issues, implicating the Riata leads in 22 deaths out of 71.

That study unleashed a firestorm of controversy, with St. Jude insisting that the clamor surrounding the December 2011 Riata recall is evidence of a "whisper campaign" fostered by rivals hoping to gain an edge in the slumping cardiac rhythm management arena.

"This has become a topic of competitive marketing," St. Jude CEO Daniel Starks told the Times over the weekend. "We have competitors going to physicians and informing them, either incompletely or mistakenly, of a competitively hostile view of the facts."

Cross-town nemesis Medtronic, on the other hand, told MassDevice.com that it conducted a parallel review over the weekend that corroborates Hauser’s findings for the Quattro lead.

"This is not a new accusation. From the very beginning of this Riata issue, St. Jude has been making claims that this is nothing more than a marketing campaign by Medtronic," spokesman Chris Garland told us. "Medtronic has reviewed the MAUDE filings, applying the search criteria that Dr. Hauser used in his paper. Our results are roughly in line with Dr. Hauser’s results."

Hauser’s manuscript reviewed data on the Riata line of defibrillator leads from the MAUDE database, culling 133 lead-related deaths. Of those, the study attributed 22 to failures in the Riata or Riata ST leads, compared to 5 for Medtronic’s Quattro Secure leads. According to St. Jude, however, 2 of the 22 deaths in the study were duplicates, 9 were the result of abrasions and another 9 can’t be assigned to specific failures because the failed leads were not returned to the company, leaving 2 that were definitively the result of electrical shorts. And the company claimed it found 377 deaths related to Medtronic’s Quattro lead, compared with Hauser’s 62, and 74 deaths related to the Riata leads, compared to Hauser’s 71.

Zipes told the Times that he’s offered to have the St. Jude data peer-reviewed, but that Hauser’s piece will stand.

"I understand industry’s pain, but I will not abrogate the rules and regulations that have served us so well," he said, according to the Old Gray Lady.

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Editor’s Note: This article is written by Ashley Boam and Mary Malarkey from the “FDA Voice” blog. Boam is an FDA’s acting Director of the Office of Policy for Pharmaceutical Quality, the Office of Pharmaceutical Quality and the Center for Drug Evaluation and Research. Malarkey is an FDA’s Director if the Office of Compliance and Biologics Quality […]